MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-27 for LIFEVEST WCD 4000 SYSTEM 10A0988 manufactured by Zoll Manufacturing Corporation.
[186144418]
Biocompatibility testing to iso 10993 was successfully completed on skin-contacting surfaces of the lifevest device as well as the blue(tm) defibrillation gel.
Patient Sequence No: 1, Text Type: N, H10
[186144419]
A us distributor contacted zoll to report that a patient reported burns on his abdomen area to a nurse at an er. Nurse reported that there were brown marks and not sure if there were burns and they were not near the lifevest. There was no alleged device malfunction contributing to the irritation. The patient presented himself to er stating that he was shocked, but then reported they were just vibrations. There are indications that the patient received a treatment event. It is unknown if the patient received any medical intervention for marks. The medical outcome of the rash is unknown as follow up attempts were unsuccessful. Reporting out an abundance of caution as further details are not know.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008642652-2020-02589 |
| MDR Report Key | 9889273 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-21 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANNA BEATTY |
| Manufacturer Street | 121 GAMMA DRIVE |
| Manufacturer City | PITTSBURGH, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 9683333 |
| Manufacturer G1 | ZOLL MANUFACTURING CORPORATION |
| Manufacturer Street | 121 GAMMA DRIVE |
| Manufacturer City | PITTSBURGH, PA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFEVEST WCD 4000 SYSTEM |
| Generic Name | WEARABLE CARDIOVERTER DEFIBRILLATOR |
| Product Code | MVK |
| Date Received | 2020-03-27 |
| Model Number | WCD 4000 |
| Catalog Number | 10A0988 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL MANUFACTURING CORPORATION |
| Manufacturer Address | 121 GAMMA DRIVE PITTSBURGH, PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2020-03-27 |